Research Assistant

Job Overview:
The Research Assistant is responsible for research study activities such as assisting in study planning and set-up, assisting with study participant visits and study close out activities. They will be required to follow specific requirements of study protocols, regulatory requirements, policies, Standard Operating Procedures (SOPs) and Work Instructions (WI). The Research Assistant may assist with recruitment and coordinate study participant visits as directed by the study team. Part time / Casual

Primary Responsibilities:
**Primary Responsibilities**:

- Assists the CRC in the coordination of assigned clinical research projects in accordance with Protocols, SOPs, WIs, and applicable regulations
- Assists the CRCs and/or laboratory technicians on studies, including assisting in required start-up activities including but not limited to the following:

- Preparing clinic source collection documents, time and events tables, and other required study materials
- Planning and collaboration with vendors (safety laboratory, bioanalytic lab) for study set-up and clinic supplies inventory
- Performs the following during the conduct of a clinical trial:

- Assists in screening activities and provides support as required
- Ensures set-up of clinic rooms, participant charts, and source document preparation prior to start of clinic visit activities
- Assists in clinic activities including, but not limited to:

- Assists in conducting clinic visits (admission, assist in dosing and randomization, discharge, and follow-up) as required
- Follows-up and assists in ensuring volunteer eligibility prior to randomization
- Witnesses investigational drug administration and other activities as delegated and required
- In collaboration with the responsible teams, conducts all study-related activities according to protocol, SOPs, WIs, and applicable regulations
- Checks for clinic updates, quality control findings, study monitor findings and addresses them with the guidance of the CRC
- Escalates observations of concern to CRCs and Investigators as appropriate
- Performs the following after the in-clinic phase of the clinical study and in preparation for site close-out:

- Assists in close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation
- Assists with other close-out activities as required (return of study supplies, archiving, etc.)
- Assists with monitoring participants’ compliance throughout the study
- Assists in addressing day-to-day participant or study issues and escalates as appropriate
- Assists with the preparation for regulatory inspections, sponsor or internal QA audits and monitoring visits, as required
- Collaborates within and between teams during process improvement exercises, internal and external meetings, and other company-related initiatives and goals
- Accommodates flexible schedules (available days, afternoons, nights, and weekends)
- Other duties as may be required and as training and experience allow
- Promotes GXP compliance across the organization
- Maintains an attitude and philosophy consistent with the company standards

**Core Competencies**:

- Familiarity with Natural Health Product Regulations
- Strong verbal and written communication skills in English (spoken and written)
- Practices leadership and professionalism skills as well as understanding the importance of teamwork necessary for conducting a clinical trial
- Takes pride in accomplished task and observes accountability and ownership
- Proficient in MS Office, Excel, and Power Point

**Education and Experience**:

- Pharmaceutical and/or clinical trial experience is an asset
- Certification and/or degree in a health, science or research related fields preferred

**Job Type**: Part-time

Work Location: In person